MUKUL KHANDELWAL
Mumbai, Maharashtra
Summary
Hardworking Business Process Analyst with a broad range of expertise seeking to leverage background to take next career step with a respected organization. Over more than 4.1 years experience in developing and initiating business intelligence solutions to improve organizational performance. Accomplished in developing and interpreting logical data models to identify opportunities for performance improvement. Demonstrated to facilitate communication between IT professionals and business leaders and clearly articulate business needs to drive organizational goals.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Business Process Lead
Tata Consultancy Services Ltd. (TCSL)
Mumbai
03.2023 - Current
- Review and pre-selection of literature as well as provision of project specific annotation in the Product Literature Information (PLI) Database
- Review of global literature, preselected by the SCP product Information Team/Global Research and Development Information (GRDI) for detection of single cases accordingly to SOP and Guidance Paper Documentation of review result in the Product Literature Information (PLI) database
- Request of full text and translation and review on script
- Initializing and entry of literature cases onto project’s Global PV Safety database Argus
- Taking care of literature articles sent by License Partner, Global Safety Leader, Medical Affairs, Regulatory or any other project employee
- Initializing and entry of license-partner literature cases which includes review of full text and also PLI related tasks
- Supports local sites in regard to questions and issues raised in context of local literature review
- Support all functions in regard to single case creation from literature review
- Takes the final decision whether a case should be created from local or global literature report.
Drug Safety Associate I
Parexel International (India), Private Limited
Mohali
09.2021 - 11.2022
- Expertise in management of ICSRs of all case types (spontaneous and solicited programs) which includes Triage, Initiation, Duplication and complete Data Entry
- Expertise in MedDRA coding in accordance with MedDRA Term Selection
- Maintaining a good working knowledge of the AE safety profile of assigned drugs/class of drugs, Reference Safety Information documents, ICH guidelines on safety and efficacy, FDA guidelines, CIOMS and New EU PV legislation
- Expertise in processing literature cases
- Expertise in handling the ERP (Enterprise Resource Planning) system
- Interacting with appropriate client personnel to resolve issues related to the processing of ICSRs in accordance with client policies
- Responding to clients/customers in a timely manner.
Drug Safety Associate
Bioclinica India Pvt. Ltd.
Mysore
07.2019 - 09.2021
- As Quality Check Reviewer, As Case Processor, As Medical Coder and Narrative Writer
Education
Master of Pharmacy - Pharmaceutics
Ramaiah University of Applied Sciences (MSRUAS)
07.2019
Bachelor of Pharmacy -
JSPM's RSCOP&R, Tathawade, Pune (SPPU, Pune)
06.2017
HSC -
Shri T.P. Bhatia Junior College of Science, Kandivali (W), Mumbai (MSBSHSE, Pune)
04.2013
SSC -
St. Xavier’s High School, Borivali (E), Mumbai (MSBSHSE, Pune)
05.2011
Skills
- Can Operate Lyophilizer, UV-Spectrophotometer (Shimadzu model no 1700 and 1900), FT-IR Spectroscopy (Shimadzu 8400 S), HPLC (LOD, LOQ, Accuracy, Precision), Probe Sonicator, DSC (Exothermic and Endothermic)
- Can handle Multi station tablet compression, Dissolution apparatus (Electrolab)
- Process Improvement
- Analytical Thinking
- Data Analysis
- Dedication towards work assigned and give best to it
- Data Assessment and Analysis
- Quality Reporting
- Presentation Skills
- Leadership skills, self-confidence and Willingness to learn new concepts and ideas involving new technologies with an ability to adapt quickly and effectively
Academic Projects Research
- Development of directly compressible pharmaceutical excipients for drug delivery.
- Development of peroral delivery system containing Bisphosphonate drug for treatment of osteoporosis.
Certification
- Published Article on project: Peroral delivery of risedronate sodium for treatment of osteoporosis. (Link)
- Patent Filed on Project: Development of Peroral delivery system containing Bisphosphonate drug for treatment of Osteoporosis (Patent Application: 201941054262, December 27, 2019).
- Licensed Registered Pharmacist
Industrial Exposure
- One-month industrial Exposure at GLPL PHARMACAPS Ltd.
Personal Information
- Hobbies: Music and Movies, Making new friends, Exploring new places and travelling (bike riding)
- Date of Birth: 07/03/95
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Languages
Hindi
First Language
English
Proficient (C2)
C2
Gujarati
Proficient (C2)
C2
Marathi
Upper Intermediate (B2)
B2
Disclaimer
I hereby declare that the information given above is true to the best of my knowledge.
Timeline
Business Process Lead
Tata Consultancy Services Ltd. (TCSL)
03.2023 - Current
Drug Safety Associate I
Parexel International (India), Private Limited
09.2021 - 11.2022
Drug Safety Associate
Bioclinica India Pvt. Ltd.
07.2019 - 09.2021
Master of Pharmacy - Pharmaceutics
Ramaiah University of Applied Sciences (MSRUAS)
Bachelor of Pharmacy -
JSPM's RSCOP&R, Tathawade, Pune (SPPU, Pune)
HSC -
Shri T.P. Bhatia Junior College of Science, Kandivali (W), Mumbai (MSBSHSE, Pune)
SSC -
St. Xavier’s High School, Borivali (E), Mumbai (MSBSHSE, Pune)
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